Government steps in to address shortage of life-saving drug

Over the last five months, companies here have been facing difficulties with suppliers of the raw material used to make the medicine, said the source.Prabha Raghavan | ET Bureau | September 30, 2016, 05:30 IST

NEW DELHI: The government has called a special meeting with companies that produce the life-saving D-Penicillamine medicine in order to remedy its shortage, which has for months plagued several patients suffering from Wilson’s disease. The central drug regulator has stepped in to address concerns over the shortage, which industry sources argue is because suppliers of the medicine’s most crucial raw material are now favouring other markets for better margins.

Wilson's disease is a rare and potentially fatal genetic disorder that causes excessive accumulation of copper in vital organs like the eyes, liver, kidneys and brain. The disease could even cause liver failure if left untreated, leaving the patient in need of a transplant.

Central Drug Standard Control Organisation (CDSCO) will meet with D-Penicillamine producers German Remedies, Panacea Biotec, Samarth Lifesciences, VHB Lifesciences and Chandra Bhagat Pharma on Friday to chart out measures to make the drug available again.

“CDSCO has received various representations regarding the non-availability of life saving drug (D-Penicillamine) in the country. As per the representations, the drug has disappeared from the market in the recent past and it is no more available in the country,” said deputy drugs controller R Chandrashekar in a notice dated September 28. “The availability of the drug is very important as there are no alternatives for the treatment of Wilson’s disease,” he added.

Panacea Biotec, one of the largest producers of the drug in India under its brand ‘Cilamin 250’, stated on Wednesday that it has made the medicine available in limited quantities in the retail market. After working with alternate suppliers, it has also resumed limited production of the drug here, it said.

D-Penicillamine is a Rs4-5 crore market in India, according to an industry source who spoke to ET on the condition of anonymity. While there is reportedly another drug—Trientine dihydrochloride—that treats the disease, it is not produced in India.

Over the last five months, companies here have been facing difficulties with suppliers of the raw material used to make the medicine, said the source.

“Once it came under price control, the drug’s prices have become low and suppliers from countries like China have not been supplying to India. Even the limited suppliers from India have begun to prefer exporting the raw material to get a better margin,” the source said.

According to the source, some companies have approached the government asking it to allow imports of the raw material on an emergency-basis as opposed to waiting for nearly half a year to import it through regular procedures.

One out of every 30,000 people are afflicted with Wilson’s, according to Wilson’s Disease Association (WDA) International.

Only in India the healthcare financing is very small when compared to the financing by the other forces rather than the patient himself or herself paying out of pocket. Having 70-75% of the expenses as out-of-pocket, in my opinion, is not a right approach to managing healthcare in a country where the patients tend to sub-optimally purchase healthcare if he/she has to pay out-of-pocket.